Medical Device Recall: What’s the Cause?

There have been a few (including those here, here and here) Class I product recalls of medical devices in the past month or so, particularly in regards to infusion devices having a higher flow rate than specified.

The financial repercussions are relatively obvious, but what’s less obvious are the root causes for these device failures, especially since they come from several different manufacturers.  What kind of evaluation processes would a quality engineer have to run through in order to determine the reason for failure?  How would his or her team have to prove the strength of their design, particularly since 2010 the FDA has been focused on preventing problems with infusion pumps due to a perceived deficiency in design and engineering?  What kinds of test data would they have to show to the FDA to validate the quality of their product, and more importantly, ensure patient health and safety?

NI Week 2011

IntraStage is going to have a booth at NI Week in Austin next week,.

If you’re going to be at NI Week, come by and visit us at booth 526-if you haven’t used our software before, take the opportunity to test out our fully functional demo software.  If you’re an existing customer, come by and get some of our giveaways.  And we’ll be announcing a new addition to the IntraStage software catalog, so check that out and the accompanying iPod contest.

Quality of supply chain components suffering from Japan Earthquake

Although there has been much talk about (and some hype perhaps) on the recent affect of the Japan earthquake on the electronic supply chain, it hit home for me when I was visiting an OEM Electronic Manufacturer this past June.  They talked about how some of their components like oscillators and capacitors etc which were normally sourced from Japan manufacturers were now needing to be sourced from secondary and tertiary suppliers.  Although of the same general specification, these parts turned out to be of inferior quality, causing failures when cycled over temperature or under corner conditions of testing. This has forced this customer to focus on more extensive testing and qualification of supplier components.

Maybe if the OEM customer received the quality data on those incoming parts, they could do their own analysis of where things are breaking down between incoming quality and what they are actually testing. An interesting article on the effect of supply chain components from the Japan Earthquake is here:

Transparency is Coming: Are You prepared to give full transparency to your OEMs today?

Transparency is Coming: Are You prepared to give full transparency to your OEMs today?

As Original Equipment Manufacturers (OEMs) seek closer ties with their Contract Manufacturers (CMs) in order to more fully control their supply chain during this uncertain economic climate, expectations on those contract manufacturers are evolving.  OEMs are purchasing or implementing solutions that will allow greater visibility of their manufacturing and test results, combining the data from in-house and outsourced manufacturing.

Many large CMs already offer these types of tools to their OEMs; however, integration of software often requires significant time and expense, and few CMs can afford the cost.  When these tools are in place, the transparency can lead to yield improvements and faster detection of issues and root causes.

We discuss this issue over at a LinkedIn discussion group here.  We encourage anyone who reads our blog to join that group and contribute to that (and other) test data management discussions.

Contract Manufacturing Tools and Practices: What’s Your Take?

Contract Manufacturing Tools and Practices: What's Your Take?

Supplier Quality

The last couple of weeks we’ve been blogging about the issues and challenges OEMs face when dealing with contract manufacturing.  One particular problem we hear again and again from OEMs is how difficult and time-consuming it is to obtain a true record of test data from contract manufacturers (and forget trying to get real-time data).  Conversely, we’ve heard from CMs that they want a better way to manage and report their manufacturing data, especially if they’re producing components for multiple OEMs.  Particularly if the CM’s contract dictates that they eat rework and scrap costs, they’ve been interested in refining their processes as efficiently as possible, but this is especially difficult without real-time, accurate manufacturing data.

With upcoming software releases from IntraStage we will be implementing additional Supply Chain module features which will help to solve what we observe to be critical problems facing both OEMs and CMs.  But the best way to solve these problems is to get feedback from our customers who are people deeply involved in this area. So please, let us know about your experiences good or bad. We would love to hear them.